White Papers

CE Marking in Europe

Three medical device directives are part of the New Approach: MDD 93/42/EEC; Active Implantable Medical Devices Directive AIMDD 90/385/EEC; and In Vitro Diagnostic Directives IVDD 98/79/EC. This white paper covers:

• Overview of CE Marking
• Review of EU Directives
• Regulatory Documentation and Notified Body Involvement
• The Declaration of Conformity
• CE Marking Q&A

Europe’s Proposed Medical Device Regulation

Highly anticipated reforms to the EU medical device regulations have been announced in recent weeks that will have major ramifications for medical and in vitro diagnostic device manufacturers active in Europe—as well as for their authorized representatives, Notified Bodies, distributors and importers. Once implemented, these proposed reforms will be the most significant changes to the EU medical device market in years. They expand the regulatory scope, establish more substantial definitions and responsibilities, and add more safety and performance requirements. Specific changes that will impact manufacturers include…

FDA 510(k) process

This white paper walks you through the process getting a medical device cleared for sale by the US FDA, how to determine the classification of your device, finding appropriate predicate devices already cleared by the FDA, the FDA quality system requirements, and online registration requirements. Also discussed are the six most common mistakes that delay a 510(k) submission.

Understanding the 2.3% US Excise Tax

Included in the US Patient Protection and Affordable Care Act (PPACA) is a 2.3% excise tax applicable to manufacturers and importers of taxable medical devices that are sold or imported in/to the United States. This white paper provides a detailed overview of the tax, to whom it applies, and how payments need to be made to the Internal Revenue Service. Also included are examples of how to calculate the tax, and explanations of when payments need to be made.